Kornimate/medical-research-clean huggingface dataset:
treatment of patients with rad001 with progressive sarcoma

Conditions: Progressive Sarcoma

Summary: the purpose of this multicenter, three-arm, exact binomial single-stage, phase ii trial is to determine the preliminary efficacy and safety of rad001 in patients with histological evidence of progressive or metastatic bone or soft tissue sarcoma.


Eligibility criteria:
inclusion criteria: histological evidence of progressive or metastatic bone or soft tissue sarcoma. the following tumor types are included: * malignant fibrous histiocytoma * liposarcoma * synovial sarcoma * malignant paraganglioma * fibrosarcoma * leiomyosarcoma * angiosarcoma including haemangiopericytoma * malignant peripheral nerve sheath tumor * sts, not otherwise specified * miscellaneous sarcoma including mixed mesodermal tumors of the uterus * osteosarcoma * ewing's sarcoma * rhabdomyosarcoma * gastrointestinal stromal tumor (only after failure or intolerance of imatinib or sunitinib in 1st and 2nd line) * alveolar soft part sarcoma (asps) * objective progression of disease may be documented by recist criteria. any of the following would be sufficient according to recist: * a 20% increase in the sum of unidimensionally measured target lesions * a new lesion * unequivocal increase in non-measurable disease. * patients must have disease not amenable to surgery, radiation, or combined modality therapy with curative intent. * ecog performance status 0 - 2. exclusion criteria: anticancer therapy within 3 weeks of enrollment including chemotherapy, hormonal therapy, immunotherapy, or radiotherapy. * the following tumor types will not be included: * gastrointestinal stromal tumor (except for patients after treatment with imatinib or sunitinib in 1st and 2nd line) * chondrosarcoma * malignant mesothelioma * neuroblastoma. * prior therapy with rad001 (everolimus) or other rapamycins (sirolimus, temsirolimus). * neurotoxicity \> grade 2 ctc. * radiation of the lung. other protocol-defined inclusion/exclusion criteria may apply

Keywords: progressive gist progressive sarcoma
benzodiazepine discontinuation in opioid agonist therapy

Conditions: Substance Use Disorders

Summary: the proposed study is a clinical trial, designed to pilot test a distress tolerance-benzodiazepine discontinuation (dt-bd) intervention for patients on opioid agonist therapy who currently use benzodiazepines. the dt-bd intervention is an adjunctive psychosocial intervention in people seeking to discontinue (bzd) use. the goal of the study is to assess the applicability and feasibility of this intervention through treatment retention and qualitative interviews with four participants who are receiving opioid agonist treatment and who regularly use bzds.

this study pilots a 13-week psychosocial intervention paired with a benzodiazepine taper with the aim of assisting individuals receiving oat discontinue benzodiazepine use. all participants will receive the same benzodiazepine (bzd) discontinuation protocol. the distress tolerance-benzodiazepine discontinuation (dt-bd) intervention consists of 14 study visits: the first visit consists of the baseline assessment and the first therapy visits, 4 subsequent weekly therapy visits, then a 9-week bzd taper. some participants may be prescribed non-benzodiazepine medications to treat the underlying conditions for which they were using bzds \[e.g. selective serotonin reuptake inhibitors (ssri) for anxiety or hypnotics for insomnia\]. data collection will occur starting at the baseline assessment.

Eligibility criteria:
inclusion criteria: 1. age 18 or older 2. receiving oat (methadone or buprenorphine) confirmed by toxicology testing for at least 90 days and on a steady dose for 2 consecutive weeks 3. regular bzd use defined by bzd use 3 or more times per week in past month by self-report and positive urine screen at time of recruitment 4. provides permission to contact current bzd prescriber if being prescribed bzds 5. speaks english 6. wants to discontinue bzd use exclusion criteria: 1. pregnant, confirmed by urine pregnancy test 2. cognitive impairment, as indicated by a score of \< 23 on the mini mental status exam 3. any past month illicit opioid, barbiturate, z-drug, cocaine, unprescribed amphetamine, or synthetic cannabinoid use determined by self-report or urine drug test 4. receiving ongoing psychosocial treatment for bzd use disorder 5. uncontrolled seizure disorder (i.e. seizure in prior 90 days), or past bzd withdrawal seizure 6. current suicidality or homicidality 7. current psychotic symptoms

Keywords: opioid agonist therapy benzodiazepine distress tolerance distress tolerance - benzodiazepine discontinuation (dt-bd) relaxation therapy (rt)
coronavirus (covid-19) outcomes registries in immunocompromised individuals australia (coria)

Conditions: HIV-1-infection; Cancer; Primary Immune Deficiency Disorder; Immunosuppression Disorders; COVID-19

Summary: coria is an observational cohort study of immunosuppressed populations who test positive for covid-19. this includes people living with hiv, cancer, acquired immunodeficiency associated with other immunosuppressive therapy, primary immunodeficiency and recipients of a solid organ transplant. participants will have routine clinical data collected with optional baseline collection and storage of a blood sample for storage . the study will be conducted in up to 30 sites within australia.


Eligibility criteria:
inclusion criteria: 1. presenting (in person or via telemedicine) for evaluation because they: * have clinical symptoms consistent with for covid-19: * fever (≥ 37.8 °c) on examination or patient reported fever (≥ 37.8 °c) or feverishness (felt febrile but did not take temperature) or any of, cough, sore throat, shortness of breath, rhinorrhoea, headache, chills, generalise myalgia, malaise, fatigue, confusion, diarrhea, nausea or vomiting * have been contacted because they have been identified as a contact to a confirmed case * have been contacted and told they tested positive for covid-19 2. have one of the following conditions affecting immune function: * known or suspected primary immunodeficiency, defined as a predisposition to infection associated with an apparent or presumed deficit of immune function * on immunosuppressive therapy * treatment with immune checkpoint inhibitors within 36 months of enrolment date * hiv infection * diagnosis of cancer within 36 months of enrolment date, excluding superficial basal cell and squamous cell carcinomas * solid organ transplantation 3. for optional biobanking only, ability to provide informed consent exclusion criteria: * nil
postoperative discomfort and ocular redness following phacoemulsification surgery

Conditions: Cataract

Summary: primary objective of the study is the assessment of the patients' discomfort and ocular redness following cataract extraction surgery by means of phacoemulsification and intraocular lens implantation.

participants will be recruited from the cataract service of the university hospital of alexandroupolis (uha) in a consecutive-if-eligible basis. by means of a custom computer randomization program all participants will randomly populate either study group (who will receive systane ultra as additional postoperative treatment) and control group (who will receive standard postoperative treatment).

Eligibility criteria:
inclusion criteria: 1. diagnosis of senile cataract with stage 2 or 3 nuclear opalescence according to the - lens opacities classification system iii (locs-3) grading scale exclusion criteria: 1. endothelial cell count less than 1900, 2. glaucoma, 3. iop-lowering medications, 4. former incisional surgery, 5. former diagnosis of corneal disease, 6. diabetes or autoimmune diseases 7. former diagnosis of dry eye disease
long-term study with clevudine

Conditions: Chronic Hepatitis B

Summary: a open-labeled phase lv study with 96 weeks of treatment period. the purpose of this study is to investigate safety and efficacy of clevudine in patients chronically infected with hepatitis b virus, hbeag positive or negative.


Eligibility criteria:
inclusion criteria * patient with dna levels \>=1 x 10\^5 copies/ml within 30 days of baseline. * patient is documented to be hbsag positive for \> 6 months. * patient has alt levels \>=80 iu/l * women of childbearing potential must have a negative urine (β-hcg) pregnancy test taken within 14 days of starting therapy. exclusion criteria. * patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy. * patients previously treated with interferon within the previous 6 months. * patients previously treated with clevudine, lamivudine, adefovir, entecavir, telbivudine or any other investigational nucleoside for hbv infection. * patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy. * patient is coinfected with hcv, hdv or hiv. * patient with clinical evidence of decompensated liver disease or hepatocellular carcinoma * patient is pregnant or breast-feeding. * patient is unwilling to use an "effective" method of contraception during the study and for up to 3 months after the use of study drug ceases. * patient has a clinically relevant history of abuse of alcohol or drugs. * patient has a significant immunocompromised, gastrointestinal, renal, hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic gb stone, neurological, cardiac, oncologic(except hcc)or allergic disease or medical illness that in the investigator's opinion might interfere with therapy. * patient has creatinine clearance less than 60ml/min as estimated by the following formula: (140-age in years) (body weight \[kg\])/(72) (serum creatinine \[mg/dl\]) \[note: multiply estimates by 0.85 for women\]
therapy to elevate cd4 counts in hiv-1 disease

Conditions: HIV Disease

Summary: for more than 20 years, alpha-1-proteinase inhibitor therapy has been the standard treatment for patients who have inherited alpha-1-proteinase inhibitor deficiency. adult patients with this condition eventually develop emphysema. most hiv-1 patients who have low viral load also have alpha-1-proteinase inhibitor deficiency. the number of cd4 cells in blood increases when alpha-1-proteinase inhibitor increases. patients will be asked to participate in a pilot study to see whether the use of zemaira® (alpha-1-proteinase inhibitor) can increase blood levels of alpha-1-proteinase inhibitor and consequently increase cd4 counts.

hiv-1 patients will be asked to participate in a pilot study to see whether the use of zemaira increases blood levels of alpha-1-proteinase inhibitor and consequently increase cd4 counts. hiv-1 patients will receive weekly treatment with zemaira for 8 weeks by intravenous infusion. blood will be collected immediately prior to each infusion. blood will be collected at each visit. exploratory assessments and not pre-specified outcome measurements will include complete blood count, lymphocyte phenotype, hiv-1 viral load, lipid levels, blood chemistry, and markers of inflammation from patient medical records. exploratory and not pre-specified outcome measures will include extended lymphocyte phenotype and lymphocyte function using residual blood collected.

Eligibility criteria:
inclusion criteria: 1. hiv-1 patients must have confirmed hiv-1 disease, diagnosed using the standard criteria and be on antiretroviral therapy. patients with inherited alpha-1 proteinase inhibitor deficiency (pizz) must not have previously received alpha-1 proteinase inhibitor therapy. uninfected volunteers will be age and gender matched. 2. hiv-1 patients must have measurable disease, defined as hiv-1 infected patients on antiretroviral therapy with undetectable hiv rna (\<500 hiv-1 rna copies/ml) and cd4 counts more than 200 and less than 400 cells/ul. 3. age at least 18 years and under 65 years. 4. hiv-1 patients must have active alpha-1 proteinase inhibitor below 11um (normal is 18-53 um). 5. hiv-1 patients must have one year history (prior to the study) with cd4 counts greater than 200 and less than 400 cells/ul. 6. volunteers must have no evidence of malignancy. exclusion criteria: 1. recent illness that will prevent the patient from participating in required study activities. 2. patients receiving other investigational agents. 3. patients with known malignancies. 4. patients with more than 500 hiv rna copies/ml. 5. patients with more than 400 cd4 cells/ul. 6. uncontrolled illness including, but not limited to, ongoing or active infection, myeloid dysplastic syndrome, anemia, bone marrow failure, digeorge syndrome, thymic disorders, or psychiatric illness/social situations that would limit compliance with study requirements.

Keywords: cd4 counts cholesterol
asc930 in patients with steroid-refractory acute graft versus host disease (sr-agvhd)

Conditions: Acute-graft-versus-host Disease

Summary: acute gvhd following allogeneic hct is an immune-triggered process, leading to profound immune dysregulation and organ dysfunction. despite pivotal advances, agvhd is one of the leading causes of non-relapse mortality in patients undergoing hct. placenta-derived dscs, isolated from the fetal membrane of maternal origin, are a type of stromal cells with well-characterized immunosuppressive properties. the current study is designed to assess the safety and efficacy of 4 intravenous (iv) doses of asc930 dsc cells in agvhd patients.


Eligibility criteria:
inclusion criteria: * participants ≥ 2 months of age * diagnosis of agvhd grade ii-iv following allogeneic hsct according to standard criteria (harris, 2016). * diagnosis of sr-agvhd according to mohty (2020) * meet one of the following criteria: * participants who are ruxolitinib-refractory, according to mohty (2020) * participants who are not eligible for soc therapy * participants who agree to receive asc930 as a second-line therapy * karnofsky/lansky performance status of at least 30 at the time of study entry * minor participants must be capable of giving written assent as appropriate per the applicable age (per local regulatory requirements). exclusion criteria: * diagnosis of active hepatic sinusoidal obstruction syndrome (sos) * presence of an active uncontrolled infection * active treatment for a hyprecoagulation disorder * evidence of diffuse alveolar hemorrhage or other active pulmonary disease * evidence of encephalopathy as defined by a change in mental status since the onset of agvhd * evidence of relapse of malignancy * receival of agents other than steroids for primary treatment of agvhd * severe allergic history to cell-based products
effect of multimodal exercise training in patients with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the study aims to examine the effects of multimodal exercise training including aerobic, strengthening and balance exercises via face-to-face and asynchronous video-based telerehabilitation on disease activity, disability level, aerobic capacity, physical activity level, balance, fatigue level and quality of life in individuals with multiple sclerosis. therefore, this study consists of two hypotheses. hypotheses: h0: multimodal exercise training has no effect on disease activity and functional status in patients with multiple sclerosis h1: multimodal exercise training has effects on disease activity and functional status in patients with multiple sclerosis

multiple sclerosis (ms) is a leading cause of disability in young adults, with symptoms varying based on lesion size, location, and disease course. these symptoms often worsen over time, significantly impacting quality of life. to manage symptoms and potentially affect disease activity, patients are often directed to exercise interventions, though the impact on disease progression is still being studied. neuroimaging, particularly magnetic resonance imaging (mri), is commonly used to monitor ms, but mri does not reveal brain activation levels, which is why functional mri is recommended for a more detailed evaluation. exercise, both face-to-face and telerehabilitation (tr), is considered an effective treatment for ms. studies show that tr increases patient adherence and can be as effective as in-person therapy. our study aims to assess the effects of a multimodal exercise program combining face-to-face and tr on disease activity and functional status in patients with ms (pwms). pwms with an expanded disability status scale (edss) score of 3.0 to 5.5 will be randomly assigned to either the multimodal exercise training group (group i) or a control group (group ii). disease activity, disability, aerobic capacity, physical activity, balance, fatigue, and quality of life will be evaluated. group i will participate in exercise training three days a week (one day in-person, two days tr) for 12 weeks. group ii will receive no exercise during this period and will be reassessed after 12 weeks.

Eligibility criteria:
inclusion criteria: * being diagnosed with multiple sclerosis by a neurologist * volunteering to participate in the study * being ambulatory * edss between 3.0-5.5 * being literate * having internet access * not having participated in a standardized physiotherapy and rehabilitation program in the last 3 months exclusion criteria: * having an orthopedic problem affecting its mobility * having psychiatric problems, severe cognitive impairment, or epilepsy in addition to the ms diagnosis * blurred vision or visual impairment * pregnancy * having had an attack or received corticosteroid treatment 3 months before participating in the study * having a disease affecting immunological parameters (infection, cancer, etc.)

Keywords: exercise physiotherapy degenerative diseases disease activity multimodal
safety and efficacy study of arq 501 in adult patients with leiomyosarcoma

Conditions: Cancer

Summary: the purpose of this study is to assess the overall response rate (orr) of persistent, recurrent or metastatic leiomyosarcoma in patients treated with arq 501.


Eligibility criteria:
inclusion criteria: * able to provide signed and dated informed consent prior to study-specific screening procedures. * histologically or cytologically confirmed leiomyosarcoma that is persistent, recurrent or metastatic. * measurable disease as defined by recist. * karnofsky performance status \>= 70% * male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after the last infusion of arq 501. * hemoglobin (hgb) \>= 10 g/dl. * absolute neutrophil count (anc) \>= 1.5 x 10\^9/l (\>= 1,500/mm3). * platelet count \>= 100 x 10\^9/l (\>= 100,000/mm3). * total bilirubin less than or equal to 1.5 x upper limit of normal (uln) or less than or equal to 3.0 x uln with metastatic liver disease. * aspartate aminotransferase (ast) and alanine aminotransferase (alt) less than or equal to 2.5 x uln less than or equal to 5.0 uln with metastatic liver disease. * creatinine less than or equal to 1.5 x uln. exclusion criteria: * received three or more prior anticancer chemotherapy regimens. * have active, uncontrolled systemic infection considered opportunistic, life threatening or clinically significant at the time of treatment. * have received anticancer chemotherapy, immunotherapy, radiotherapy, surgery or investigational agents within four weeks of first infusion. * have symptomatic or untreated central nervous system (cns) involvement. * are pregnant or breastfeeding. * previous exposure to arq 501.
musicotherapy in the reduction of fatigue in women with breast or gynecological cancer under radiotherapy

Conditions: Breast Cancer; Uterine Cancer; Ovarian Cancer

Summary: objetive: to study the influence of musicotherapy in reduction of fatigue related to cancer in patients with breast's or gynecology's cancer, during the radiotherapy treatment.

methods: this is a randomized controled study (control group - cg e musicotherapy group - mtg) wich values fatigue, life's quality, anxiety, depression by using evaluative instruments functional assessment of cancer therapy: fatigue (fact-f), beck depression inventory (bdi), beck anxiety inventory (bai) in three different moments (during first week of radiotherapy, in the intermediate phase's week and during the last week of radiotherapy) for patients of both groups. women allocated in mtg, in addition to the scales described above, answered the musicotherapy questionary (mq), and the subjective impression of the subject's questionary in last meeting. musicotherapy sessions were individual and lasted an average of 40 minutes. music therapeutic techniques used were musical audition (ma) and therapeutic musical audition (tma).

Eligibility criteria:
inclusion criteria: * patients with breast and gynecological cancer with indication for radiotherapy * performance status 0,1 exclusion criteria: * hemoglobin \< 10mg/dl * patients in psychotherapy during the study * use of antidepressants * patients presenting more than one cancer type

Keywords: breast cancer gynecological cancer radiotherapy fatigue musicotherapy
transorbital ultrasound and other markers for prognosis prediction after cardiac arrest

Conditions: Cardiac Arrest

Summary: in sudden cardiac arrest patients with return of spontaneous circulation, brain damage is one of the main determinants of short-term mortality and poor prognosis (cpc 3-5). it is important to properly select group of patients in whom treatment is futile. according to current guidelines, multimodal approach is recommended. optic nerve sheath diameter measured by ultrasound is non-invasive, fast, low-cost and readily available bed-side method, but evidence for its use as neuroprognostication modality is limited to only few small studies. the aim of this study is to evaluate validity of onsd as neuroprognostication method at larger cohort of patients, compare it with other established methods and compare ultrasound and ct measurement of onsd.

additional relevant mesh terms: cardiac arrest, cardiovascular diseases, optic nerve sheath diameter.

Eligibility criteria:
inclusion criteria: * age of 18 years or older * out of hospital cardiac arrest of non-traumatic cause with cpr and subsequent rosc * glasgow coma scale (gcs) ≤ 7 or sedation 30 minutes after rosc achievment exclusion criteria: * unavailable first measurment of the optic nerve sheath diameter (onsd) measured by transorbital ultrasonography 24±6 hours after rosc achievement * refractory cardiac arrest * craniocerebral injury * intracranial tumor * active intracranial bleeding * haemorrhagic stroke and/or subarachnoid haemorrhage in the last 3 months * facial trauma affecting the eye area * active neuroendocrine tumor, small cell lung cancer, non-small cell lung * cpc 3-5 before cardiac arrest * sclerosis multiplex and/or optic neuritis of other etiology
prosat - long term effect of probiotics on satiety

Conditions: Obesity; Appetite Regulation

Summary: the aim of the prosat study is to examine the effects of a probiotic capsule containing lb. casei on subjective appetite sensation, ad libitum energy intake, and appetite hormone response in a single meal test and to determine whether the acute effects persist after daily supplementation of the probiotic capsule.


Eligibility criteria:
inclusion criteria: * healthy men and women * normal to slight overweight (bmi: 22-28 kg/m2) * 20-45 years of age exclusion criteria: * smoking * daily medicine use (oral contraceptives excluded) * use of pre- and probiotic supplements and foods * blood donation 3 months prior to the study * hb \< 7,5mmol/l * chronic illnesses such as hyperlipidemia, diabetes inflammatory diseases * pregnancy or breastfeeding * elite athletes (\>10 hours hard exercise/week) * vegetarians